DOSE-RELATED EFFICACY OF LEVOMETHADYL ACETATE FOR TREATMENT OF OPIOIDDEPENDENCE - A RANDOMIZED CLINICAL-TRIAL

Objective.-To compare the clinical efficacy of different doses of levo methadyl acetate hydrochloride (known as LAAM) in the treatment of opi oid dependence. Design.-A randomized controlled, double-blind, paralle l group, 17-week study. Setting.-Outpatient facilities at Johns Hopkin s University Bayview Medical Center, Baltimore, Md. Patients.-Opioid-d ependent volunteers (N=180) applying to a treatment-research clinic. I ntervention.-Thrice-weekly (Monday/Wednesday/Friday) oral LAAM dose co nditions of 25/25/35 mg, 50/50/70 mg, and 100/100/140 mg and nonmandat ory counseling.Main Outcome Measures.-Retention in treatment, self-rep orted heroin use, and opioid-positive urine specimens. Results.-Retent ion was independent of subjects' sex and dose. Self-reported heroin us e decreased in a dose-related manner. At final assessment, patients in the high-dose condition reported using heroin 2.5 of 30 days as compa red with 4.1 or 6.3 days for patients in the medium-dose and low-dose conditions, respectively (high dose vs low dose, P<.05); urinalysis re sults were similarly dose related. Overall, 20 (34%) of 59 patients in the high-dose condition remained opioid-abstinent for 4 consecutive w eeks, as compared with 8 (14%) of 59 in the medium-dose and 7 (11%) of 62 in the low-dose conditions (P<.01). Self-report and urinalysis dat a are consistent with a greater than 90% reduction in illicit opioid u se by the high-dose group relative to pretreatment levels. Conclusion. -Opioid substitution treatment with LAAM substantially reduces illicit opioid use. The clinical efficacy of LAAM is positively related to do se.